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CTRI Number  CTRI/2024/04/065009 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 12/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   retention of cement after application of Silver modified atraumatic restorative technique as compared to Atraumatic restorative treatment  
Scientific Title of Study   Comparative evaluation of the effectiveness of Silver-modified atraumatic restorative technique (SMART) with Atraumatic restorative treatment (ART) on management of dental caries among 5 years old School children: A Randomised Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saniya Shaikh 
Designation  Postgraduate Resident  
Affiliation  sinhgad Dental College and Hospital Pune 
Address  Department of Public Health Dentistry, Department number 8 ,Sinhgad Dental College and Hospital, Pune, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041
Department of Public Health Dentistry, Department number 8 ,Sinhgad Dental College and Hospital, Pune, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA
411042
India 
Phone  7875450026  
Fax    
Email  saniyass23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kadambari Ambildhok 
Designation  Reader 
Affiliation  sinhgad Dental College and Hospital Pune 
Address  Department of Public Health Dentistry, Department number 8 ,Sinhgad Dental College and Hospital, Pune, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041

Pune
MAHARASHTRA
411041
India 
Phone  8378999073  
Fax    
Email  kadambar.ambildhok@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kadambari Ambildhok 
Designation  Reader 
Affiliation  sinhgad Dental College and Hospital Pune 
Address  Department of Public Health Dentistry, Department number 8 ,Sinhgad Dental College and Hospital, Pune, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041

Pune
MAHARASHTRA
411041
India 
Phone  8378999073  
Fax    
Email  kadambar.ambildhok@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, Department number 8 ,Sinhgad Dental College and Hospital, Pune, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 
 
Primary Sponsor  
Name  Saniya Shaikh 
Address  8a, 2nd Floor, B Wing, Amol Sagar Estate Bhawani Peth Amol Sagar Estate Bhawani Peth PUNE, MAHARASHTRA 411042 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kadambari Ambildhok  SINHGAD TECHNICAL EDUCATION SOCITYS RMD SINHGAD SCHOOL OF COMPUTER STUDIES  Department of Public Health Dentistry, Department number 8 ,Sinhgad Dental College and Hospital, Pune, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041
Pune
MAHARASHTRA 		 8378999073

kadambari.ambildhok@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ICD level-1 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  38% Silver diamine Fluoride  Silver-modified atraumatic restorative technique (SMART)- is defined as a technique to halt decay and seal teeth using two products: silver diamine fluoride (SDF) and glass ionomer cement (GIC) restoration in a single appointment. Intervention will be given for 6 months. 
Comparator Agent  Glass Ionomer cement   Atraumatic restorative treatment (ART)- is defined as removal of soft, demineralized tooth tissue using hand instrument alone, followed by restoration of the tooth with an adhesive restorative material. Comparator agent will be given for 6 months. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Participants of age group 5 years old.
Parents/caregivers of the children who are willing to participate in the study
and give informed consent.
Caries present as per International Caries Detection and Assessment System
(ICDAS)31 (Annexure V) code 3 & 4 in deciduous molar (D & E) bilaterally in
maxillary and/or mandibular arch.
Caries involving occlusal surface only 
 
ExclusionCriteria 
Details  Participants showing uncooperative behaviour.
Participants who will not be present at the time of the study.
Participants with proximal and multi surface dental caries.
Participants with designated primary molars having existing restorations.
Participants with designated molars having deep carious lesions with close
proximity to the pulp.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To compare SMART with ART on management of dental caries assessed
using Modified US Public Health Service Criteria (USPHS) Criteria and ART
restoration criteria 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduce Dental caries progression   3 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   17/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The data collection procedure will be as follows: - Participants fulfilling the inclusion criteria will be selected. At Baseline Demographic Details of the participants and Informed consent from parents or guardians will be taken. ICDAS Score of the tooth (D and/or E) will be recorded. Using Coin Toss Method, one side of the Oral Cavity will be subjected to SMART and other side will be subjected to ART. Isolation of tooth with the help of Cotton rolls and Excavation of the soft caries with spoon excavator will be done. Group A (SMART)- 38% SDF will be applied directly to the lesion with an applicator tip, left for 2 minutes, and restored with GIC. Group B (ART)- Cavity will be filled with GIC and with the help of finger-press technique excessive restorative material along the slopes of the cusps will be removed. At Follow up At 1, 3 and 6 Months the teeth will be assessed using USPHS Criteria32 (Annexure VI) and ART restoration criteria33 (Annexure VII) -If there is any dislodgement/ fracture of the restorative material and observance of secondary caries under the restoration the participant will be excluded after re-restoring the tooth. 
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